Registration Dossier

Administrative data

Description of key information

Skin corrosion
Skin corrosion testing in vitro using the EPISKIN™ Reconstituted Human Epidermis Model has been conducted for FLL Samples 2, 3, 4 and 6. There was no evidence of corrosivity for 3, 60 and 240 minute exposures for any of the samples supporting a classification of “non-corrosive” for the FLL Substances.
Skin irritation potential in vitro testing has also been conducted for FLL Samples 2, 3, 4 and 6 using the EPISKIN™ Reconstituted Human Epidermis Model. There was no evidence of skin irritation following exposure to any of the samples supporting a classification of “non-irritant” for the FLL Substances.
Eye irritation:
Eye irritation ex vivo using the rabbit enucleated eye test has been conducted for FLL Samples 2, 3, 4 and 6. Comparison of control and exposed eyes for 60 to 240 minute exposures indicated that for all samples, severe eye irritancy was unlikely in vivo.
Eye irritation in vivo has also been evaluated for FLL Samples 3 and 4 using the acute eye irritation test in the rabbit. The samples were classified as either a mild irritant (FLL Sample 3) or a minimal irritant (FLL Sample 4) according to a modified Kay and Calandra classification system. For the test organisms, there were no irreversible effects on the eyes, and not corneal opacity or iritis observed. Although conjuctivital redness was rated “2” after 1 hr, it was rated at 1 or less at 24 hr and 48 hr and completely reversed by 72 hr.
These combined results for the FLL Substances indicate that the substances do not cause irreversible effects on the eye/serious damage to eyes (Category 1) and are not considered irritating to eyes (Category 2).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin corrosion

Skin corrosion testing in vitro using the EPISKIN™ Reconstituted Human Epidermis Model has been conducted for FLL Samples 2, 3, 4 and 6. There was no evidence of corrosivity for 3, 60 and 240 minute exposures for any of the samples supporting a classification of “non-corrosive” for the FLL Substances. Skin irritation potential in vitro testing has also been conducted for FLL Samples 2, 3, 4 and 6 using the EPISKIN™ Reconstituted Human Epidermis Model. There was no evidence of skin irritation following exposure to any of the samples supporting a classification of “non-irritant” for the FLL Substances.

Eye irritation:

Eye irritation ex vivo using the rabbit enucleated eye test has been conducted for FLL Samples 2, 3, 4 and 6. Comparison of control and exposed eyes for 60 to 240 minute exposures indicated that for all samples, severe eye irritancy was unlikely in vivo. Eye irritation in vivo has also been evaluated for FLL Samples 3 and 4 using the acute eye irritation test in the rabbit. The samples were classified as either a mild irritant (FLL Sample 3) or a minimal irritant (FLL Sample 4) according to a modified Kay and Calandra classification system. For the test organisms, there were no irreversible effects on the eyes, and not corneal opacity or iritis observed. Although conjuctivital redness was rated “2” after 1 hr, it was rated at 1 or less at 24 hr and 48 hr and completely reversed by 72 hr. These combined results for the FLL Substances indicate that the substances do not cause irreversible effects on the eye/serious damage to eyes (Category 1) and are not considered irritating to eyes (Category 2).